How To Avoid Pharma's Top 5 FDA Form 483 Triggers

By James Jardine, MasterControl

The riskiest wager a pharmaceutical company can make is to gamble that its questionable quality practices will go unnoticed by the U.S. Food and Drug Administration (FDA). As proof, the agency has issued an average of 645 Form 483 reports to drug companies in each of the past five years. ⁽¹⁾

What Is FDA 483?

While you might hear it called by many names — “inspectional observation,” “Form 483,” or simply the dreaded digits “483” — an FDA Form 483 inspection observation report refers to the notice a company receives from the agency that highlights conditions found by FDA inspectors during routine observations that they’ve deemed to be objectionable.

The prevailing hope among ethical professionals in the industry is that errors resulting in Form 483s are most commonly due to oversight rather than sloppiness or fraudulence. Whatever the cause, however, the efforts to resolve these types of quality and accountability issues are indicators of the pharma industry’s integrity and commitment to safety.